FDA Investigating Paclitaxel Coated Balloons and Eluting Stents

Prompted by a recent publication in the Journal of the American Heart Association that suggests a possible increased risk of death at two years and beyond in patients treated with vascular balloons coated with paclitaxel or stents that release paclitaxel, FDA said it is evaluating data and working directly with manufacturers to better understand this issue.

A meta-analysis of randomized trials recently concluded that there is an increased risk of death for patients treated with paclitaxel‐coated balloons and paclitaxel-eluting stents in the femoral and/or popliteal arteries of the lower limbs. The analysis, which was published in late December in the Journal of the American Heart Association, has prompted FDA to investigate.

The agency issued a letter last week recommending that doctors continue to monitor patients who have been treated with these devices and discuss the benefits and risks of all available treatment options for patients with peripheral artery disease (PAD). FDA said it currently believes the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used as indicated. The agency also said it encourages prompt reporting of adverse events or suspected adverse events with these devices through its MedWatch reporting system.

FDA said it is evaluating available long-term follow-up data to determine if there are any long-term risks associated with paclitaxel-coated products. The agency said it is also conducting additional statistical analyses to clarify the presence and magnitude of any long-term risks and is working directly with manufacturers of these devices to better understand this issue.

Shortly after the study was published, investigators of the BASIL-3 trial and the SWEDEPAD 1 and SWEDEPAD 2 trials paused recruitment efforts. Konstantinos Katsanos, MD, PhD of Patras University Hospital in Rion, Greece is the lead author of the analysis. VIVA Physicians, a not-for-profit organization dedicated to peripheral artery disease (PAD) education and research, said it will host a forum in February to discuss the Katsanos analysis.